Method and system for providing data management in integrated analyte monitoring and infusion system

ABSTRACT

Methods and systems for providing therapy related data management are provided. The subject systems include one or more device components, and at least one memory storage unit and at least one data storage unit associated with such one or more device components. The device components may include one or more of an analyte monitoring system, a fluid delivery device and a remote terminal. The subject methods include use of the subject systems to optimize treatment of a patient.

RELATED APPLICATION

The present application is a continuation of U.S. patent applicationSer. No. 11/462,982 filed Aug. 7, 2006, entitled “Method and System forProviding Data Management in Integrated Analyte Monitoring and InfusionSystem,” the disclosure of which is incorporated herein by reference forall purposes.

BACKGROUND

With increasing use of pump therapy for Type 1 diabetic patients, youngand old alike, the importance of controlling the infusion device such asexternal infusion pumps is evident. Indeed, presently available externalinfusion devices typically include an input mechanism such as buttonsthrough which the patient may program and control the infusion device.Such infusion devices also typically include a user interface such as adisplay which is configured to display information relevant to thepatient's infusion progress, status of the various components of theinfusion device, as well as other programmable information such aspatient specific basal profiles.

The external infusion devices are typically connected to an infusion setwhich includes a cannula that is placed transcutaneously through theskin of the patient to infuse a select dosage of insulin based on theinfusion device's programmed basal rates or any other infusion rates asprescribed by the patient's doctor. Generally, the patient is able tocontrol the pump to administer additional doses of insulin during thecourse of wearing and operating the infusion device such as for,administering a carbohydrate bolus prior to a meal. Certain infusiondevices include food database that has associated therewith, an amountof carbohydrate, so that the patient may better estimate the level ofinsulin dosage needed for, for example, calculating a bolus amount.

However, in general, most estimation or calculation of a bolus amountfor administration, or a determination of a suitable basal profile, forthat matter, are educated estimates based on the patient's physiology asdetermined by the patient's doctor, or an estimate performed by thepatient. Moreover, the infusion devices do not generally includeenhancement features that would better assist the diabetic patients tocontrol and/or manage the glucose levels.

In view of the foregoing, it would be desirable to have an approach toprovide methods and system for data processing associated with apatient's monitored analyte levels for providing semi automatic orautomatic recommendation based on the processed data such as, forexample, therapy profile, glucose level pattern recognition, and thelike.

SUMMARY

In accordance with one embodiment of the present invention, there isprovided method and system for detecting a predetermined rate ofincrease in an analyte level of a patient over a predefined time period,and associating a temporal identifier associated with the detectedpredetermined rate of increase in the analyte level of the patient.

These and other objects, features and advantages of the presentinvention will become more fully apparent from the following detaileddescription of the embodiments, the appended claims and the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a block diagram illustrating a therapy management system forpracticing one embodiment of the present invention;

FIG. 2 is a block diagram of a fluid delivery device of FIG. 1 in oneembodiment of the present invention;

FIG. 3 is a block diagram illustrating the remote terminal of FIG. 1 forperforming data processing in accordance with one embodiment of thepresent invention;

FIG. 4 is a flowchart illustrating analyte level associated dataprocessing related to meals in accordance with one embodiment of thepresent invention;

FIG. 5 is a flowchart illustrating therapy management related dataprocessing in accordance with one embodiment of the present invention;and

FIG. 6 is a flowchart illustrating time of day related data processingassociated with meal events in accordance with one embodiment of thepresent invention.

DETAILED DESCRIPTION

FIG. 1 is a block diagram illustrating an insulin therapy managementsystem for practicing one embodiment of the present invention. Referringto FIG. 1, the therapy management system 100 includes an analytemonitoring system 110 operatively coupled to a fluid delivery device120, which may be in turn, operatively coupled to a remote terminal 140.As shown the Figure, the analyte monitoring system 110 is, in oneembodiment, coupled to the patient 130 so as to monitor or measure theanalyte levels of the patient. Moreover, the fluid delivery device 120is coupled to the patient using, for example, an infusion set and tubingconnected to a cannula (not shown) that is placed transcutaneouslythrough the skin of the patient so as to infuse medication such as, forexample, insulin, to the patient.

Referring to FIG. 1, in one embodiment the analyte monitoring system 110in one embodiment may include one or more analyte sensors subcutaneouslypositioned such that at least a portion of the analyte sensors aremaintained in fluid contact with the patient's analytes. The analytesensors may include, but not limited to, short term subcutaneous analytesensors or transdermal analyte sensors, for example, which areconfigured to detect analyte levels of a patient over a predeterminedtime period, and after which, a replacement of the sensors is necessary.

The one or more analyte sensors of the analyte monitoring system 110 iscoupled to a respective one or more of a data transmitter unit which isconfigured to receive one or more signals from the respective analytesensors corresponding to the detected analyte levels of the patient, andto transmit the information corresponding to the detected analyte levelsto a receiver device, and/or fluid delivery device 120. That is, over acommunication link, the transmitter units may be configured to transmitdata associated with the detected analyte levels periodically, and/orintermittently and repeatedly to one or more other devices such as thefluid delivery device and/or the remote terminal 140 for further dataprocessing and analysis.

The transmitter units of the analyte monitoring system 110 may be, inone embodiment, configured to transmit the analyte related datasubstantially in real time to the fluid delivery device 120 and/or theremote terminal 140 after receiving it from the corresponding analytesensors such that the analyte level such as glucose level of the patient130 may be monitored in real time. In one aspect, the analyte levels ofthe patient may be obtained using one or more of discrete blood glucosetesting devices such as blood glucose meters, or continuous analytemonitoring systems such as continuous glucose monitoring systems.

Additional analytes that may be monitored, determined or detected theanalyte monitoring system 110 include, for example, acetyl choline,amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase(e.g., CK-MB), creatine, DNA, fructosamine, glucose, glutamine, growthhormones, hormones, ketones, lactate, peroxide, prostate-specificantigen, prothrombin, RNA, thyroid stimulating hormone, and troponin.The concentration of drugs, such as, for example, antibiotics (e.g.,gentamicin, vancomycin, and the like), digitoxin, digoxin, drugs ofabuse, theophylline, and warfarin, may also be determined.

Moreover, within the scope of the present invention, the transmitterunits of the analyte monitoring system 110 may be configured to directlycommunicate with one or more of the remote terminal 140 or the fluiddelivery device 120. Furthermore, within the scope of the presentinvention, additional devices may be provided for communication in thetherapy management system 100 including additional receiver/dataprocessing unit, remote terminals (such as a physician's terminal and/ora bedside terminal in a hospital environment, for example. In addition,within the scope of the present invention, one or more of the analytemonitoring system 110, the fluid delivery device 120 and the remoteterminal 140 may be configured to communicate over a wireless datacommunication link such as, but not limited to RF communication link,Bluetooth® communication link, infrared communication link, or any othertype of suitable wireless communication connection between two or moreelectronic devices, which may further be uni-directional orbi-directional communication between the two or more devices.Alternatively, the data communication link may include wired cableconnection such as, for example, but not limited to RS232 connection,USB connection, or serial cable connection.

The fluid delivery device 120 may include in one embodiment, but notlimited to, an external infusion device such as an external insulininfusion pump, an implantable pump, a pen-type insulin injector device,a patch pump, an inhalable infusion device for nasal insulin delivery,or any other type of suitable delivery system. In addition, the remoteterminal 140 in one embodiment may include for example, a desktopcomputer terminal, a data communication enabled kiosk, a laptopcomputer, a handheld computing device such as a personal digitalassistant (PDAs), or a data communication enabled mobile telephone.

Referring back to FIG. 1, in one embodiment, the analyte monitoringsystem 110 includes a strip port configured to receive a test strip forcapillary blood glucose testing. In one aspect, the glucose levelmeasured using the test strip may in addition, be configured to provideperiodic calibration of the analyte sensors of the analyte monitoringsystem 110 to assure and improve the accuracy of the analyte levelsdetected by the analyte sensors.

FIG. 2 is a block diagram of a fluid delivery device of FIG. 1 in oneembodiment of the present invention. Referring to FIG. 2, the fluiddelivery device 120 in one embodiment includes a processor 210operatively coupled to a memory unit 240, an input unit 220, a displayunit 230, an output unit 260, and a fluid delivery unit 250. In oneembodiment, the processor 210 includes a microprocessor that isconfigured to and capable of controlling the functions of the fluiddelivery device 120 by controlling and/or accessing each of the variouscomponents of the fluid delivery device 120. In one embodiment, multipleprocessors may be provided as safety measure and to provide redundancyin case of a single processor failure. Moreover, processing capabilitiesmay be shared between multiple processor units within the fluid deliverydevice 120 such that pump functions and/or control may be performedfaster and more accurately.

Referring back to FIG. 2, the input unit 220 operatively coupled to theprocessor 210 may include a jog dial, key pad buttons, a touch padscreen, or any other suitable input mechanism for providing inputcommands to the fluid delivery device 120. More specifically, in thecase of a jog dial input device, or a touch pad screen, for example, thepatient or user of the fluid delivery device 120 will manipulate therespective jog dial or touch pad in conjunction with the display unit230 which performs as both a data input and output units. The displayunit 230 may include a touch sensitive screen, an LCD screen, or anyother types of suitable display unit for the fluid delivery device 120that is configured to display alphanumeric data as well as pictorialinformation such as icons associated with one or more predefined statesof the fluid delivery device 120, or graphical representation of datasuch as trend charts and graphs associated with the insulin infusionrates, trend data of monitored glucose levels over a period of time, ortextual notification to the patients.

Referring to FIG. 2, the output unit 260 operatively coupled to theprocessor 210 may include an audible alarm including one or more tonesand//or preprogrammed or programmable tunes or audio clips, or vibratoryalert features having one or more pre-programmed or programmablevibratory alert levels. In one embodiment, the vibratory alert may alsoassist in priming the infusion tubing to minimize the potential for airor other undesirable material in the infusion tubing. Also shown in FIG.2 is the fluid delivery unit 250 which is operatively coupled to theprocessor 210 and configured to deliver the insulin doses or amounts tothe patient from the insulin reservoir or any other types of suitablecontainment for insulin to be delivered (not shown) in the fluiddelivery device 120 via an infusion set coupled to a subcutaneouslypositioned cannula under the skin of the patient.

Referring yet again to FIG. 2, the memory unit 240 may include one ormore of a random access memory (RAM), read only memory (ROM), or anyother types of data storage units that is configured to store data aswell as program instructions for access by the processor 210 andexecution to control the fluid delivery device 120 and/or to performdata processing based on data received from the analyte monitoringsystem 110, the remote terminal 140, the patient 130 or any other datainput source.

Within the scope of the present invention, the fluid delivery device 120may be configured to ascertain these consecutive glucose readings fromthe data stream received from the analyte monitoring system 110.Moreover, the predefined time period may additionally include any othersuitable time period where the monitored analyte levels may provideinformation associated with the patient's physiological condition aspertains to the insulin therapy and diabetes management. For example,the predefined time period may include a 4-7 day period (or longer orshorter as may be appropriate), where the fluid delivery device 120 maybe configured to receive the glucose readings at a specific time of theday (for example, at 7 am in the morning). In this case, the consecutiveglucose readings may include each measured glucose level at 7 am in themorning for the 4-7 day period.

FIG. 3 is a block diagram illustrating the remote terminal of FIG. 1 forperforming data processing in accordance with one embodiment of thepresent invention. Referring to FIG. 3, the remote terminal 140 in oneembodiment includes a processor unit 310 operatively coupled to astorage unit 320. The storage unit 320 in one embodiment includes one ormore of a volatile memory and non-volatile memory for storing, forexample, program instructions associated with the operation of theremote terminal 140 for execution by the processor unit 310, andfurther, for storing analyte related data as well as infusion relateddata.

Referring back to FIG. 3, the processor unit 310 is further operativelycoupled to an input unit 330, and an output unit 340, as well as a powersupply unit 350. In one embodiment, the power supply unit 350 isconfigured to provide power to each of the components of the remoteterminal 140 described above, and further, to effectively manage powerbased on instructions received from the processor unit 310. The inputunit 330 may be configured to receive one or more instructions, commandsor data from a patient via, for example, a keyboard device, a mousedevice, or any other similar type of input devices, and for providingthe received one or more instructions, commands or information, to theprocessor unit 310 for further processing and control.

Additionally, the output unit 340 in one embodiment is configured tooutput one or more data or information under the control of theprocessor unit 310. For example, in one embodiment, the output unit 340may include a visual output unit such as a display unit, an audio outputunit, such as a speaker unit, or a tactile output unit, such as avibratory unit. In one embodiment, one two or more of such outputcomponents may be combined to either sequentially or simultaneouslyoutput the corresponding output signals under the command and control ofthe processor unit 310.

FIG. 4 is a flowchart illustrating analyte level associated dataprocessing related to meals in accordance with one embodiment of thepresent invention. Referring to FIG. 4, a predetermined rate of increasein analyte level over a predefined time period is detected (410). Forexample, the rate of increase in the analyte level may be predefined orpreprogrammed in the processor unit 310 (FIG. 3) to correspond orcorrelate to a meal event. That is, in the event that a rapid peak orsudden spike is detected in the monitored analyte level, the processorunit 310 is configured to associate such event with a predefined mealevent.

Referring back to FIG. 4, thereafter, the detected predetermined rate ofincrease in analyte level is associated with a time and date flag (420).Then, the associated time and date flag is stored in a memory (430), forexample in the storage unit 320 (FIG. 3). It is then determined whetherthe number of the time and date flags is greater than a predeterminednumber (440). That is, in one embodiment, it is determined whether thenumber of time and date flags associated with each associatedpredetermined rate of increase in monitored analyte levels exceeds apredetermined number. In one embodiment, the number of time and dateflags is associated with the number of meals that the patient ingestsduring a predetermined time period. That is, in one embodiment, eachrapid increase in the analyte level is associated with a meal event ofthe patient.

In this manner, in one embodiment, each meal event of the patient may beassociated with a time and date flag and stored in a database with anassociated glucose level. Accordingly, based on the monitored analytelevels, in one embodiment, each meal event may be lined up for furtherprocessing without the need for the patient to individually lineup eachmeal event. That is, in one embodiment of the present invention, mealrelated pattern recognition may be performed and executed automaticallywithout the manual data association by the patient for each meal timeand date information and the associated carbohydrate information.

FIG. 5 is a flowchart illustrating therapy management related dataprocessing in accordance with one embodiment of the present invention.Referring to FIG. 5, the stored monitored analyte levels over apredetermined time period is retrieved (510). Thereafter, the therapyadministration profile over the predetermined time period is retrieved(520). For example, in one embodiment, the retrieved therapyadministration profile may include one or more, but not limited to,stored basal profiles, carbohydrate and/or correction bolus amountadministered, temporary basal profiles administered, and the like.

Referring again to FIG. 5, an optimal therapy profile is determinedbased on the retrieved monitored analyte levels and the therapyadministration profile (530). Thereafter, the determined optimal therapyprofile is output (540), for example, on the display unit 340 (FIG. 3)for review and/or further analysis by the patient, or the patient'shealthcare provider. In this manner, in one embodiment of the presentinvention, it is possible to provide an automated pattern recognitionfor therapy administration profiles such as basal profiles and/or bolusamounts, to assist the healthcare providers in analyzing the monitoredanalyte levels in conjunction with the executed therapy administrationprofiles.

FIG. 6 is a flowchart illustrating time of day related data processingassociated with meal events in accordance with one embodiment of thepresent invention. Referring to FIG. 6, the meal schedule of the patientfor a predetermined time period is retrieved (610). Thereafter, themonitored analyte levels for the predetermined time period is retrieved(620), for example, from the storage unit 320 (FIG. 3) of the remoteterminal 140 (FIG. 1). Thereafter, the monitored analyte levels arearranged or realigned based on the meal types for the predetermined timeperiod (630), and the arranged or realigned monitored analyte levels areoutput (640) on the display unit 340, for example.

That is, in one embodiment, based on the time of date information of apatient, and the associated monitored analyte levels of the patient,time based events may be associated with the corresponding monitoredanalyte levels. For example, for shift workers with irregular workschedule such as alternating day and night shifts, it would be possibleto lineup meal events for such workers based on the time and dateinformation and the associated monitored analyte levels so as toeffectively and meaningfully perform data processing based on the intakeof food and the monitored analyte levels.

A method in accordance with one embodiment of the present inventionincludes detecting a predetermined rate of increase in an analyte levelof a patient over a predefined time period, and associating a temporalidentifier associated with the detected predetermined rate of increasein the analyte level of the patient.

The predetermined rate of increase over a predefined time period mayinclude a change in the analyte level exceeding a predeterminedpercentage over the predefined time period, where the predefined timeperiod may include one of less than 5 minutes, less than 30 minutes, orless than one hour.

In another aspect, the predetermined percentage may include one of lessthan 15 percent, less than 50 percent, or less than 80 percent.

The method may also include storing the temporal identifier associatedwith the detected predetermined rate of increase in the analyte level ofthe patient.

The temporal identifier in one embodiment may include one or more of atime information or a date information.

In one aspect, the temporal identifier may include a meal event.

A method in accordance with another embodiment includes retrieving oneor more stored analyte levels of a predetermined time period, retrievingone or more stored therapy administration profile for the predeterminedtime period, determining an optimal therapy profile based on theretrieved one or more stored analyte levels and the retrieved one ormore stored therapy administration profile.

The method may include outputting the optimal therapy profile.

In one embodiment, the retrieved one or more stored therapyadministration profile may include a pre-programmed one or more basalprofiles.

In a further aspect, the predetermined time period may include one of aone day period, a 3 day period, or less than 8 day period.

The optimal therapy profile may include, in one embodiment, a modifiedone or more stored therapy administration profiles.

A method in accordance with yet another embodiment of the presentinvention includes retrieving a meal schedule for a predetermined timeperiod, retrieving monitored analyte levels for the predetermined timeperiod, and arranging the monitored analyte levels based on one or moremeal types of the meal schedule for the predetermined time period.

The method may also include outputting the arranged monitored analytelevels.

The meal schedule in one embodiment may include one or more time periodassociated with breakfast, lunch or dinner.

In a further aspect, arranging the monitored analyte levels may includeassociating a respective analyte level for each retrieved meal schedule.

The predetermined time period in yet a further aspect may include one ormore of a 3 day period, a seven day period, or less than 14 day period.

A system for providing diabetes management in accordance with stillanother embodiment includes a storage unit configured to store one ormore data associated with monitored analyte levels, a processor unitoperatively coupled to the storage unit, and configured to perform oneor more processes to detect a predetermined rate of increase in ananalyte level of a patient over a predefined time period, and associatea temporal identifier associated with the detected predetermined rate ofincrease in the analyte level of the patient.

The predetermined rate of increase over a predefined time periodincludes a change in the analyte level exceeding a predeterminedpercentage over the predefined time period.

The various processes described above including the processes performedby the processor 210 in the software application execution environmentin the fluid delivery device 120 as well as any other suitable orsimilar processing units embodied in the analyte monitoring system 110and the remote terminal 140, including the processes and routinesdescribed in conjunction with FIGS. 4-6, may be embodied as computerprograms developed using an object oriented language that allows themodeling of complex systems with modular objects to create abstractionsthat are representative of real world, physical objects and theirinterrelationships. The software required to carry out the inventiveprocess, which may be stored in the memory unit 240 (or in a similarstorage device in the analyte monitoring system 120 and in the storageunit 320 of the remote terminal 140 for execution by the processor unit310) of the processor 210, may be developed by a person of ordinaryskill in the art and may include one or more computer program products.

Various other modifications and alterations in the structure and methodof operation of this invention will be apparent to those skilled in theart without departing from the scope and spirit of the invention.Although the invention has been described in connection with specificpreferred embodiments, it should be understood that the invention asclaimed should not be unduly limited to such specific embodiments. It isintended that the following claims define the scope of the presentinvention and that structures and methods within the scope of theseclaims and their equivalents be covered thereby.

What is claimed is:
 1. An apparatus, comprising: one or more processors;and a memory operatively coupled to the one or more processors forstoring instructions which, when executed by the one or more processors,cause the one or more processors to associate, without user input, ameal event with a rate of change of monitored analyte level when therate of change exceeds a predetermined threshold level, to determine ifa number of rates of change of the monitored analyte level over apredetermined time period associated with the meal event exceeds apredetermined number, to perform an automated pattern recognition basedon the rates of change of the monitored analyte level over thepredetermined time period associated with the meal event, and todetermine an optimal medication administration profile based on one ormore medication administration profiles, the rates of change of themonitored analyte level and the automated pattern recognition when thenumber of the rates of change of the monitored analyte level over thepredetermined time period associated with the meal event exceeds thepredetermined number.
 2. The apparatus of claim 1, further comprising anoutput unit operatively coupled to the one or more processors to outputthe optimal medication administration profile.
 3. The apparatus of claim1, wherein the one or more medication administration profiles includesone or more of a pre-programmed basal profile or a preprogrammed bolusdose.
 4. The apparatus of claim 1, wherein the predetermined time periodincludes one of a one day period, a 3 day period, or less than an 8 dayperiod.
 5. The apparatus of claim 1, wherein the predetermined timeperiod includes one or more time periods associated with a time of dayfor the meal event.
 6. The apparatus of claim 1, wherein theinstructions, when executed by the one or more processors, cause the oneor more processors to associate the meal event with a meal time and dateinformation.
 7. The apparatus of claim 1, wherein the instructions, whenexecuted by the one or more processors, cause the one or more processorsto associate the meal event with carbohydrate information.
 8. Theapparatus of claim 1, wherein the optimal medication administrationprofile includes a modified medication administration profile.
 9. Theapparatus of claim 1, wherein the instructions, when executed by the oneor more processors, cause the one or more processors to execute deliveryof medication based on the determined optimal medication administrationprofile.
 10. The apparatus of claim 1, wherein the instructions, whenexecuted by the one or more processors, cause the one or more processorsto associate, without user intervention, the meal event with a time anddate flag and stored in a database with an associated glucose level. 11.A method for providing therapy related data management in an analytemonitoring and infusion system, comprising: providing an analytemonitoring and infusion system comprising: an analyte sensor fordetecting analyte levels, a transmitter for transmitting analyte levelsusing a communication link, a remote terminal comprising a processingunit for receiving analyte levels, and an external fluid delivery devicein communication with the remote terminal; generating signals associatedwith a monitored analyte level by the analyte sensor positioned in fluidcontact with interstitial fluid under a skin surface; determining, bythe processing unit of the remote terminal, a rate of change of themonitored analyte level based on the generated signals received from thetransmitter unit; associating, without user input, by the processingunit of the remote terminal, a meal event with the rate of change of themonitored analyte level when the rate of change exceeds a predeterminedthreshold level; determining, by the processing unit of the remoteterminal, if a number of rates of change of the monitored analyte levelover a predetermined time period associated with the meal event exceedsa predetermined number; performing, by the processing unit of the remoteterminal, an automated pattern recognition based on the rates of changeof the monitored analyte level over the predetermined time periodassociated with the meal event; and determining, by the processing unitof the remote terminal, an optimal medication administration profilebased on one or more medication administration profiles, the rates ofchange of the monitored analyte level and the automated patternrecognition when the number of the rates of change of the monitoredanalyte level over the predetermined time period associated with themeal event exceeds the predetermined number.
 12. The method of claim 11,further comprising outputting the optimal medication administrationprofile to a display unit of the remote terminal.
 13. The method ofclaim 11, wherein the one or more medication administration profilesincludes one or more of a pre-programmed basal profile or apreprogrammed bolus dose.
 14. The method of claim 11, wherein thepredetermined time period includes one of a one day period, a 3 dayperiod, or less than an 8 day period.
 15. The method of claim 11,wherein the predetermined time period includes one or more time periodsassociated with a time of day for the meal event.
 16. The method ofclaim 11, wherein the meal event is associated with a meal time and dateinformation.
 17. The method of claim 11, wherein the meal event isassociated with carbohydrate information.
 18. The method of claim 11,wherein the optimal medication administration profile includes amodified medication administration profile.
 19. The method of claim 11,further including executing delivery of medication with the fluiddelivery device based on the determined optimal medicationadministration profile.
 20. The method of claim 11, further comprisingassociating, without user intervention, the meal event with a time anddate flag, and storing the meal event and time and date flag in adatabase with an associated glucose level.